FDA 510(k)

增材醫學腳趾畸形系統

K 號：K163593 · 2017-06-20

決定日期2017-06-20

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Additive Orthopaedics Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K163593. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Additive Orthopaedics Bunion System?

Additive Orthopaedics Bunion System is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K163593.

When did Additive Orthopaedics Bunion System receive FDA 510(k) clearance?

Additive Orthopaedics Bunion System received FDA 510(k) clearance on 2017-06-20, under 510(k) number K163593.

Who is the listed applicant for Additive Orthopaedics Bunion System?

The FDA 510(k) record lists Additive Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Additive Orthopaedics Bunion System?

The FDA product code for Additive Orthopaedics Bunion System is HRS.

其他以 Additive Orthopaedics, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：HRS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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